MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515306
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ infusion adapter c100 leaked chemotherapy medication from the interface port during use.The following information was provided by the initial reporter: "leaking of chemotherapy drug from interface port of rubber port of iv bag and bd infusion adaptor.".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Pr 8880884 follow up mdr for device evaluation: one unused sample was provided to our quality team for investigation.Functional testing was performed, connecting the device to an infusion bag with liquid in attempt to recreate the reported incident.It was found the product functioned as intended and no leakage from the infusion adapter was observed.A device history review was performed for reported lot 2102211, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the reported lot were used for additional evaluation.The product was visually inspected, there was no damage or other defects observed on any of the infusion adapters.Leakage testing was performed and in all cases the product functioned as intended and no leakage was observed.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification.All retained samples along with the returned product underwent these evaluations and product was verified to meet required limits, including proper spike length and diameter.Based on the available information and sample evaluation, we cannot identify a root cause related to our product or manufacturing process at this time.It is important to ensure all connections are secure when using this product.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.H3 other text : see manufacturer narrative.
Event or Problem Description
It was reported that the bd phaseal¿ infusion adapter c100 leaked chemotherapy medication from the interface port during use.The following information was provided by the initial reporter: "leaking of chemotherapy drug from interface port of rubber port of iv bag and bd infusion adaptor." there was no impact on patient/hcp.

• Brand Name: BD PHASEAL¿ INFUSION ADAPTER C100
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17821594
• Report Number: 3003152976-2023-00420
• Device Sequence Number: 20384868
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: 00382905153068
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 515306
• Device Lot Number: 2102211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown